Quality testing on off-shore drug manufacturing

[lance]

Yesterday there was a media report about quality testing of imported, developing world manufacturers of medications. Over a backdrop of a vat of something called gutter sludge being stirred prior to being used in the manufacturing process the commentator spoke of quality testing being performed at more than yearly intervals.
Last year I experienced a horrible time staying in range--rollercoasting in the worst way while taking generic Taro. Within a week of changing to brand name Coumadin INR's were normal and still are.
This is something to consider of INR's don't make sense.

 

[dick0236]

I had the same trouble with Taro earlier this year. My INR, after being very stable for a couple years, went to the low end and stayed there on Taro...even as I increased the dosage. I switched back to my previous warfarin manufacturer(Barr Labs) and it has gone back to my comfort level....around 3. I agree that the warfarin manufacturer is one of the FIRST things to consider if INR takes a strange direction.

 

[lance]

Hi Dick
It should have been--but it wasn't. It was the last, I'd been taking Taro for years without incident. In the future it will be should problems occur again.
Sandra

 

[Freddie]

Hi Sandra, do you think I could find this media report on line? Does it speak of warfarin or drugs in general? My INR has gone somewhat wacky and I've been taking TARO, just don't know which generic brand to switch to. APO-warfarin and now TARO have given me a rash - one area, same location and no I have changed soaps or anything like that.

 

[Protimenow]

I've used Taro in the past, with no issues. I've gotten it locally and from India - with the same biologic response.

I have a hard time believing that drug manufacturers would be careless about their processes - they potentially have a much larger market than the U.S. can give them, and it would make little sense for a company to injure its customer base.

I've run into a slightly different issue - meter related - and perhaps having nothing to do with my change in Warfarin. I've gotten used to my InRatio reporting between .3 and .7 higher than the labs. I'm not uncomfortable with a reported INR of 3.0 or above - to me, it suggests that I'm in range. Yesterday, doing parallel testing with my ProTime 3, I got a 1.5. I repeated it later - still 1.5. The manufacturer of the ProTime meter and cuvettes still hasn't called me back. Protime USED to be very accurate - very close to the labs -- I've upped my dose of warfarin from 7.5/day to 8/day (just in case there's any validity to the ProTime result), but suspect that ProTime has produced a bad batch. I kind of wonder if there's something about the different supplier of warfarin that may affect the way that it runs an INR.

 

[lance]

Hi Freddie
It was on CTV and the voiceover was by an MD rederring to a medical journal. It's a sorry state of affairs all right. The Ontario premier is all for cheaper drugs for seniors to save money for the province.
Maybe if you e-mailed CTV thet might be able to help.

 

[Protimenow]

We should also consider that it's financially good for the drug makers to discredit generics - particularly those made overseas. Perhaps some of these 'reports' should be taken with a grain of salt, or very carefully evaluated.

I can't imagine any country - no matter how corrupt - allowing its citizens to take ineffective or dangerous 'prescription' medications without cracking down on the manufacturers or distributors of this junk. (I can see adulterated illicit drugs, perhaps, but for medications that are supposed to serve a medically valid purpose, it just doesn't make sense to me). (Sure, a company may be able to make short term profits, for a while, but once the deception is discovered, the consequences are probably pretty severe.)

 

[yotphix]

For what it's worth, I've taken APO and TARO and a couple of others with no apparent change in my INR over the years. And, for whatever THIS is worth, I asked a pharmacist in San Diego whether he would personally use warfarin from a Mexican pharmacy (his competition since many Americans cross the border for cheap drugs). He said he wouldn't hesitate because the stuff is so cheap to make properly that there is no point in cheating or counterfeiting. That doesn't say that the quality control will be up to snuff, just that there is no incentive to do it wrongly.

 

[lance]

Yotphix
What size tablets do you take?
FWIW following my horrible experience I'll never take Taro again.
Even under the best circumstances mistakes can be made and without frequent quality testing these errors are passed on to the unsuspecting consumer. There's a reason drug manufacturers won't reveal the country of origin they source their ingredients from and I find this wortrisome.

 

[dick0236]

I made the switch from Coumadin to generic wararin 8 to 10 years ago and have periodically switched between Taro and Barr with little affect on my INR.......until earlier this year. After being on Barr Lab warfarin for a couple years, my Pharmacy switched contracts from Barr to Taro early in 2012. My INR immediately dropped to the low 2s from the low 3s....no other drug, diet, or lifestyle changes....so I suspected the warfarin. I've switched back to Barr and my INR immediately returned to, and is now stable, above 3. Earlier this year I raised a question with this Board concerning this and was given info (from a pharmacist on this Board) that the APPROVE TOLERANCE BETWEEN MANUFACTURERS IS +/- 20%. That indicates that a 5mg tablet could vary from 4mg to 6mg depending on the supplying manufacturer.....and that's a lot. Because of the broad, and acceptable FDA tolerance, I intend to stay with one brand of warfarin....and not switch back and forth between warfarin brands....as I have done in the past.

PS: the brand I have chosen is Barr.......for now.......

 

[njean]

I made the switch from Coumadin to generic wararin 8 to 10 years ago and have periodically switched between Taro and Barr with little affect on my INR.......until earlier this year. After being on Barr Lab warfarin for a couple years, my Pharmacy switched contracts from Barr to Taro early in 2012. My INR immediately dropped to the low 2s from the low 3s....no other drug, diet, or lifestyle changes....so I suspected the warfarin. I've switched back to Barr and my INR immediately returned to, and is now stable, above 3. Earlier this year I raised a question with this Board concerning this and was given info (from a pharmacist on this Board) that the APPROVE TOLERANCE BETWEEN MANUFACTURERS IS +/- 20%. That indicates that a 5mg tablet could vary from 4mg to 6mg depending on the supplying manufacturer.....and that's a lot. Because of the broad, and acceptable FDA tolerance, I intend to stay with one brand of warfarin....and not switch back and forth between warfarin brands....as I have done in the past.

PS: the brand I have chosen is Barr.......for now.......

How does one know who the supplying manufacturer is, Dick? I can't find that information on my Rx bottles.....I guess I can call the pharmacy...

 

[njean]

How does one know who the supplying manufacturer is, Dick? I can't find that information on my Rx bottles.....I guess I can call the pharmacy...

Just found the answer. In tiny, tiny letters on the bottom of the bottle, it reads: MFR: BMS. I called CVS and it is Bristol-Meyers Squibb.

 

[dick0236]

Just found the answer. In tiny, tiny letters on the bottom of the bottle, it reads: MFR: BMS. I called CVS and it is Bristol-Meyers Squibb.

Njean, you are taking brand name Coumadin.....right? Bristol-Meyers Squibb is the current owner of the brand name and is the only manufacturer of Coumadin.

 

[chaconne]

I looked at the bottle of Warfarin that Kaiser Permanente provides and it's Taro. I've had unexplained fluctuations in my INR. I wonder if any of it could be due to poorer tolerances in Taro. My guess is that this is the cheapest brand?

 

[Protimenow]

I guess that saving a penny a pill (perhaps) may add up for Kaiser over time, but the advantage is lost if the lab or clinic needs to run an extra test to verify a funny result.

I'm sure that Taro probably works just fine for a lot of people. I wonder if Kaiser - or any group, for that matter - even monitors who the supplier for a certain medication is in order to determine any user anomalies that may result from switching between one generic vendor to aonther.

 

[Mom2izzy]

I work for a pharmaceutical company in Quality Assurance. Based on what I hear, I prefer to avoid drugs from India or China, but I don't avoid all generics. In regards to product being able to be made cheaply as a a reason to believe people won't try to counterfeit the drug...I wouldn't bet on it...the ingredients may be cheap, but pharmaceutical grade equipment and facilities for appropriately controlled manufacturing and testing are most definitely not. I will get off my miniature soapbox now...sorry for the commercial interruption.

 

[lance]

A couple of years ago when cats were succumbing to kidney disease it was discovered the Chinese were adding melamine to pet foods. Melamine artificially boosted protein in the food (cheap). Luckily the food I used wasn't affected--my dogs are fine. The pet food manufacturers didn't test for melamine--plastic.
So I contacted three manufacturers asking if they sourced warfarin ingredients from China. They said that they had very high quality control which led me to believe that they do and were ashamed to admit it because their answer was evasive.
Also several years ago more than one hospitalized patient on heparin died because the heparin (sourced from Chinese pig intestines was contaminated--that was in the US.
These two incidents are worrisome.

 

[tom in MO]

The year of the Melamine scandal, >75% of the problematic foriegn made drugs all came from one generic drug plant in Canada...not the Far East. That's info from the FDA. The Melamine problem occured because there is not the same controls on food additives as there are on drug products; that's probably why they talked to you about quality control.

The suppliers of pharmaceutical ingredients are trade secrets and their names will not be released for competitive business purposes, not to hide problems. People or firms have to execute non-disclosure agreements in order to get any manufacturing information.

 

[lance]

The year of the Melamine scandal, >75% of the problematic foriegn made drugs all came from one generic drug plant in Canada...not the Far East. That's info from the FDA. The Melamine problem occured because there is not the same controls on food additives as there are on drug products; that's probably why they talked to you about quality control.

The suppliers of pharmaceutical ingredients are trade secrets and their names will not be released for competitive business purposes, not to hide problems. People or firms have to execute non-disclosure agreements in order to get any manufacturing information.

Hi Tom
By "foreign" you mean Canda, OK. Those same manufacturers refused to say yeah or nay to Chinese ingredients. At that time I'd never experienced problems with warfarin management and was on Taro. Last year that all changed and I remembered the dialogue with the manufacturers from years ago. I hope Coumadin remains the same because I don't want a recurrence of last year's problem. Until it occurred why would testing be done for plastic in pet food anyway? More recently children in China were sickened and some died because of faulty ingredients in the formula they were given. When the problem recognized blame was attached to tghe manufacturers and some were hanged.
Does the information you found from the FDA state how ofte quality testing is done on warfarin?
Cheers

 

[Mom2izzy]

The suppliers of drug ingredients should be a matter of public record. It has to be registered with the FDA.